A randomized study of the efficacy and safety of injectable poly-L-lactic acid versus human-based collagen implant in the treatment of nasolabial fold wrinkles

作者：Narins Rhoda S^*; Baumann Leslie; Brandt Fredric S; Fagien Steven; Glazer Scott; Lowe Nicholas J; Monheit Gary D; Rendon Marta I; Rohrich Rod J; Werschler Wm Philip

来源：Journal of the American Academy of Dermatology, 2010, 62(3): 448-462.

DOI：10.1016/j.jaad.2009.07.040

• aesthetic
• dermal filler
• injectable device
• injectable poly-L-lactic acid
• soft-tissue augmentation

Background: Injectable poly-l.-lactic acid (PLLA) is a synthetic; biodegradable, biocompatible polymer device.
Objective: We sought to compare the efficacy and safety of injectable PLLA with human-derived collagen in treating nasolabial fold wrinkles.
Methods: In this randomized; evaluator-blinded, parallel-group, multicenter study, subjects received injectable PLLA (n = 116) or collagen (n = 117) injections (1-4 visits, 3-week intervals). Wrinkle Assessment Scale scores were calculated at screening; posttreatment week 3; months 3, 6, 9, and 13 (injectable PLLA or collagen groups); and months 19 and 25 (injectable PLLA group). Safety data were obtained from subject interviews and case report forms.
Results: Injectable PLLA significantly improved mean Wrinkle Assessment Scale scores (all time points, P < .001). Improvements (up to 25 months after last treatment) were significantly greater (P < .001) than with collagen for posttreatment months 3 to 13.
Limitations: Mostly white women and subjects with Fitzpatrick skin types 11 and III were included.
Conclusion: Injectable PLLA provides well-tolerated; effective, and long-lasting (up to 25 months) nasolabial fold wrinkle correction. (J Am Acad Dermatol 2010;62:448-62.)

• 出版日期2010-3